Monday, 30 November 2020

How close is Costa Rica to getting the Pfizer Covid-19 vaccine?

Pfizer is one of the companies with which Costa Rica negotiates with to obtain doses for 1.5 million people; however, the product is still under study and regulatory approvals must be passed.

QCOSTARICA – The pharmaceutical Pfizer and the biotechnology company BioNTech announced, this Monday morning, the intermediate results of their clinical trial to test a possible vaccine against covid-19.

Pharmaceutical giant Pfizer and biotech firm BioNTech have said their coronavirus vaccine was more than 90% effective in preventing Covid-19 among those without evidence of prior infection.

The researchers indicate that there is a 90% success rate with this experimental vaccine.

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Pfizer is one of the six pharma with which Costa Rica is negotiating an eventual purchase of doses, as reported by the Minister of Health, Daniel Salas, days ago.

“Thanks to the agreement signed with Pfizer and BioNTech, in 2021 we will receive vaccines for 1.5 million people,” said Costa Rica President Carlos Alvarado Quesada, through his Twitter account, after hearing the announcement.

“Our first interim analysis says that our global study provides evidence that the vaccine could effectively prevent covid-19,” Ugur Sahin, co-founder of BioNTech, told reporters.

The official statement indicates that, according to current projections, there will be 50 million doses by the end of 2020 and 1.3 billion doses during 2021.

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“We are one step closer to giving the people of the world a much-needed product that they end up in this global crisis,” said Albert Bourla, CEO of Pfizer.

What does this mean? How good is 90% effective? Are we close to a definitive vaccine? When would Costa Rica have access to this product?

The first information that we must be clear about is that these are “halfway” results, they are not yet final and the trial continues to run. That said, yes, it is good news, and indicates that everything is going (so far) smoothly.

If successful, once the entire process is completed, Costa Rica would have 3 million doses of this vaccine for 1.5 million people, according to the president’s tweet.

By the time that happens, the Comisión Nacional de Vacunación y Epidemiología (CNVE) – National Vaccination and Epidemiology Commission –  already has work in progress on prioritizing risk groups, as explained by the Minister Health in an interview with La Nación, last Tuesday.

“We know that the most vulnerable groups will be the first (to receive the vaccine). With repeated exposures, for example, health personnel or the elderly or those who have two or more risk factors,” said Salas, who considers that the inoculation would begin “sometime in the first quarter of 2021”, although he did not specify if this is the option of Pfizer and BioNTech, or of one of the other pharmaceutical companies.

What we know and don’t know about the Pfizer-BioNTech vaccine

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The results are based on the first interim analysis of Phase 3 of the study, and evaluated 94 confirmed cases of Covid-19 in trial participants.

The BNT162b2 vaccine, as it is known so far, since there is no commercial name yet, is in phase III clinical trials. This is the last stage of testing before (if there are successful results) being submitted to regulatory agencies for approval.

  1. The vaccine announcement comes from a press release, not validated data. The results were reported Monday on Pfizer’s website. The company did not publish trial data at all, let alone any peer-reviewed findings.

2. The numbers driving the announcement are minuscule. Phase 3 clinical trials are where a vaccine is tested against the virus in the real world. Pfizer and BioNTech enrolled 43,538 participants around the world and randomly sorted them into two groups: one that received the vaccine and one that received the placebo. Then the company waited to see how many confirmed Covid-19 infections emerged.

3. With those caveats in mind, the vaccine has a high efficacy. The results do indicate that the vaccine will offer protection to most people who get it. The reported 90% efficacy means that if 10 people received the vaccine, at least nine of them will have protection against the virus compared to the placebo.

4. This particular approach to a vaccine (likely) works. One thing that’s been remarkable about the push for a Covid-19 vaccine is the rise of new vaccine technologies. Prior vaccines used whole viruses, or portions of them, to generate immunity. But several companies, including Pfizer and BioNTech, are using an mRNA-based approach that involves genetic material. Here, the instructions for making a piece of the virus are inserted into the body where human cells read the instructions. Cells then manufacture the virus fragment. The immune system then identifies it and builds up protection against it.

The results posted Monday also indicate that the vaccine is aiming at the right target. The BNT162b2 vaccine codes for the spike protein of SARS-CoV-2, the virus that causes Covid-19. The spike protein is what the virus uses to break into cells and hijack their machinery to make copies of itself. Researchers reasoned that if they could teach the body to target the spike protein and block it, the immune system could stop the infection. The Pfizer and BioNTech results show that this logic is sound.

5. This would be a tricky vaccine to distribute. Vaccines can be very fragile, with stringent storage requirements. According to the World Health Organization (WHO), more than half of all vaccines in the world go to waste, mainly because they spoil due to flaws in temperature control.

Pfizer and BioNTech’s BNT162b2 vaccine requires storage as low as -80°C. That may be a logistical nightmare for distributing the vaccine, as thousands of costly, new ultra-cold freezers would be needed. Pfizer is also developing a custom box that can keep the vaccine cold in transit.

6. Pfizer and BioNTech didn’t take US government money to develop the vaccine, but they may get money to manufacture it. Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, boasted to the New York Times that the company didn’t receive any funding from Operation Warp Speed. That’s the $10 billion program from the Department of Health and Human Services aimed at delivering 300 million doses of a Covid-19 vaccine by January 2021.

“We were never part of the Warp Speed,” Jansen told the Times. “We have never taken any money from the U.S. government, or from anyone.” But the US government did agree to buy at least 100 million doses of Pfizer and BioNTech’s vaccine if it clears clinical trials.

7. The timeline for when a vaccine might be rolled out is still up in the air. The fact that Pfizer and BioNTech detected 94 Covid-19 cases in their pool of volunteers so soon after enrolling their clinical trial shows that the research is progressing quickly. But the companies still have to finish the trial. Recall that the endpoint is 164 confirmed infections in the trial pool.

That said, the companies may be close to the threshold needed to file for an Emergency Use Authorization from the FDA, which would allow the vaccine to be made available to people in high-exposure roles for Covid-19. Pfizer and BioNTech said they expect to reach the necessary benchmark for an emergency authorization by the third week of November.

That means the first doses of this vaccine going out, if they clear their benchmarks, are likely several weeks, if not months, away.

With reporting from Vox.com and NYTimes.com

 

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Ricohttp://www.theqmedia.com
"Rico" is the crazy mind behind the Q media websites, a series of online magazines where everything is Q! In these times of new normal, stay at home. Stay safe. Stay healthy.

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